Responsible to define, maintain and oversee the IT strategy regarding adherence to applicable global regulatory requirements (i.e. 21 CFR Part 11, Annex 11). This position will provide partnership across the business (i.e. Manufacturing, Quality, Validation, Compliance, etc.) through quality management and quality oversight activities intended to ensure overall global regulatory adherence. This includes partnering with key business stakeholders in the development of the computer system validation corporate strategy, provide subject matter expertise and lead the IT component of the corporate wide CSV program. Provide CSV expertise while working closely with the validation and quality teams to deliver on key elements of the quality and compliance programs in support of business objectives.
This position will have responsibility and ownership of all IT CSV related policies and procedures, including the CSV Master Plan, ensuring they meet organization needs and remain aligned to global regulatory guidance. This activity includes partnering with corporate training to ensure the organization is properly trained on CSV concepts, policies, processes and procedures.